Non Hodgkin's Follicular Lymphoma Clinical Trial
Official title:
Phase II Study of VELCADE in Combination With Rituximab in Patients With Relapsed or Progressed Non Hodgkin's Follicular Lymphoma
The aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.
Eligible patients will receive the combination Velcade-rituximab for up to a total of 6
cycles of Velcade and 6 infusion of rituximab.
Patients will be evaluated for clinical, laboratory, imaging parameters at baseline, during
study treatment, at the end of the treatment and during follow up (every 6 months for 3
years). In the first stage, 17 patients will be treated. An interim analysis will be
performed after recruitment of the first 17 evaluable patients. Aim of this analysis is to
determine preliminary the activity of the treatment.If > 7 responses are observed, the
accrual is continued and 24 additional patients are treated up to a total of 41. If ≤ 21
respond, the treatment is rejected as ineffective. If 22 or more respond, the treatment is
judged promising for further development.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment